Cleared Traditional

K252391 - Revi System (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252391 · Bluewind Medical , Ltd. · Gastroenterology & Urology device
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Dec 2025
Decision
134d
Days
Class 2
Risk

K252391 is an FDA 510(k) clearance for the Revi System. Classified as Implanted Tibial Electrical Urinary Continence Device (product code QXM), Class II - Special Controls.

Submitted by Bluewind Medical , Ltd. (Herzliya, IL). The FDA issued a Cleared decision on December 12, 2025 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5305 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bluewind Medical , Ltd. devices

Submission Details

510(k) Number K252391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2025
Decision Date December 12, 2025
Days to Decision 134 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 130d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QXM Implanted Tibial Electrical Urinary Continence Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5305
Definition An Implanted Tibial Electrical Urinary Continence Device Is An Implanted Prescription Device That Receives Power From A Non-implanted External Power Source To Provide Electrical Stimulation Of The Tibial Nerve In Proximity To The Ankle. The Device Is Intended For The Treatment Of Overactive Bladder Related Symptoms Of Urge Urinary Incontinence, Urinary Urgency, Urinary Frequency And Nocturia.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

BioVision , Ltd.
Elissa Burg

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.